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USP Public Statement on Completion of Evaluations of Recall of USP 33–NF 28

Type of Posting: General Announcement

Posting Date: 04–Oct–2010

Reports Point to Factors Contributing to the Need to Recall Standards Compendia,
Steps to Ensure the Quality of Future Volumes

In January 2010, the United States Pharmacopeial Convention (USP) recalled the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28) after errors were discovered in the publication. These errors occurred as a result of an initiative known as the Monograph Redesign Project, in which all of the monographs in the compendia were redesigned to streamline presentation, improve the ease of use, and update and harmonize terminology. The Project was not intended to change any requirements of the monograph standards, which are relied upon by those who market and regulate drugs in the United States. USP has now completed its evaluations of the recall, and is reaffirming its commitment to the redesign of USP–NF monographs while taking the steps necessary to ensure that users can have confidence in the quality of the publication.

Under the direction of the USP's Board of Trustees, three evaluations were performed: one by USP senior management, one by a Board-appointed Task Force consisting of Board, Convention and Council of Experts volunteers, and another by an outside law firm. While the focus and emphasis of these evaluations varied somewhat, they reached similar conclusions regarding the reasons for the errors in the publication and the need to recall it. "I am satisfied that these reviews identified the root causes leading to the errors, and that USP management acted appropriately to quickly recall USP 33–NF 28 once the extent of the errors became known," said Duane Kirking, Pharm.D., Ph.D., Chair of the USP Board of Trustees. "By taking quick action, management was able to recall the publication well before its official date, and help avoid potential patient safety or other issues that otherwise might have resulted from the use of erroneous text. I also am convinced that the redesign project remains vital to improved usability of these important compendia—and that USP management and staff are ready, willing, and able to move this project forward with assurance of accuracy," he said.

The factors identified by the reports as contributing to the need to recall USP 33–NF 28 included:

Lack of Appreciation of Scope and Complexity of Project. The Monograph Redesign Project proved to be far more complicated than originally thought—both in terms of complexity and sheer number of monographs involved. Underestimating this was the single most significant factor, as it drove many decisions about how the Project was managed. At the outset, a decision not to include experienced scientific liaisons in the redesign project for USP–NF, as was done with the redesign of USP's Food Chemicals Codex (FCC) standards, precluded a full understanding of the magnitude of the task.

Inadequate Staffing and Resourcing. Much of the initial redesign work was outsourced to consultants with limited training from USP rather than performed by experienced scientific staff. Multiple review cycles involving numerous different reviewers, many of whom also were unfamiliar with the monographs they were reviewing and lacked a common understanding of the new format, multiplied the possibilities for inconsistencies and errors.

Unrealistic Deadlines. USP decided that the redesign needed to be completed all at once, so that old and new formats would not co-exist in the redesigned publication. This resulted in unrealistic deadlines that compromised quality.

Quality Assurance/Quality Control. The Project was not handled through USP's normal systems and management processes. As a result, typical quality assurance protections and controls were not utilized.

Priority and Focus. The Project was not viewed or treated as a major priority for USP, and was not given sufficient visibility or attention.

Lack of Strong Management and Accountability. USP senior management was not adequately involved in supervising the Project and there was a lack of clear accountability and responsibility. The Project lacked a strong, cross-functional management team to ensure organization-wide oversight.

Corporate Culture. The culture of USP for participants in the Project did not appear to sufficiently encourage open communication and dialogue about issues relating to its execution.

According to USP Chief Executive Officer Roger L. Williams, M.D., "Equipped with a good understanding of the causes for the errors and a much greater appreciation of the enormity of the project, USP has been taking corrective and preventative actions. With the completion of these reports and the backing of the Board of Trustees, USP staff is dedicated to doing the hard and important work necessary over the next several years to ensure the best possible quality standards are available for manufacturers, regulators, and health care practitioners."

The following corrective and preventative actions have been implemented to ensure the future success of the Project:

Staffing. All redesign work is now being performed by staff scientific liaisons who have intimate knowledge of the monographs. New staff is being added to ensure adequate resources, and USP's publications department is being organized to provide greater integration of publication functions, closer coordination with scientific staff, and improved overall accountability for publications quality.

Management. Redesign work is now explicitly included in the responsibilities of the scientific liaisons and their managers, with the division chief ultimately responsible and accountable. A cross-functional project team led by this chief will ensure comprehensive planning, careful oversight, and full consideration of any emerging issues.

Process. Numerous process improvements have been made. A simplified and automated workflow has been created to track all monographs. The redesign style guide has been reviewed by a team of knowledgeable staff to resolve and clarify issues and to ensure continued consistency. Extensive training is being provided.

Priority. The importance of the Project is being conveyed to staff through incorporation into FY'11 organizational and individual performance metrics, with an emphasis on quality as well as progress toward Project completion.

Quality Assurance/Quality Control. USP's QA group will perform regular process audits prior to publication. Errors will be analyzed and steps taken to address underlying causes.

Timing. Rather than attempting to redesign all monographs at once, which was the approach used for USP 33–NF 28, USP will redesign monographs on a prioritized basis gradually over several years until all monographs appear in the improved format. The timeline, including a 2015 target completion date, will be reviewed periodically and adjusted based on experience.

Culture/Communication. USP is engaged in initiatives to promote its core values of integrity, respect, transparency, shared decision-making, commitment to excellence, and quality improvement at all levels of the organization. The need to report issues and challenges as they arise will be emphasized, and the new project team will provide a forum to encourage discussion and proactively identify and address any concerns.

Board Chair Dr. Kirking affirms that "USP's Board looks forward with renewed commitment to the presentation of redesigned monographs in USP–NF that will facilitate their use and promote USP's mission of improving health through public standards."